FIRST E-LIQUID COMPANY RECEIVES PMTA for Substantive Review

Aug 18, 2020

FIRST E-LIQUID COMPANY RECEIVES PMTA
for Substantive Review

Congratulations to AVAIL Vapor who announced today that a PMTA for a flavored e-liquid submitted to the FDA was accepted for substantive review. As we all know the FDA is accepting all vaping manufactures PMTAs by Sept. 9, 2020 if they intend to sell on the legal market after the date. This is the first e-liquid to make it into the Substantive Review for further study by federal regulators. Avail now has a year until the agency. Issues it’s final decision on whether they will be made Legal for market.
All products that wish to be on the market must submit PMTA’s for review by the FDA. This will allow them to go though a review by the FDA as the second part before they are passed through. So far no one has passed through but also no one has been accepted for substantive review.
Until now, the only products made by an independent vaping manufacturer known to be accepted for substantive review have been E-Alternative Solutions’ Leap and Leap Go devices, and prefilled, sealed Leap pods. EAS announced on July 8 that their Leap PMTA submissions had been accepted for substantive review.
Juul Labs announced its PMTA submission in July, and all of the tobacco companies that sell vaping products have submitted applications, the most recent being Imperial Brands/Fontem Ventures’ myblu. Except for Juul, all of those companies can finance the cost of their PMTA submissions with cigarette sales.

That is not the case for small, independent vaping businesses.